Cellular Aging and Neurobiology of Depression Study

Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Age Range:21 - 60
Start Date:December 2010
End Date:February 2020
Contact:Owen Wolkowitz, MD

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Neurosteroid Metabolism and the Antidepressant Effects of Serotonin Specific Reuptake Inhibitors (SSRI's)

We are conducting an eight week longitudinal study to learn if blood levels of certain
naturally occurring compounds and genetic markers differ between patients with depression and
healthy adults who are not depressed, and if any such differences relate to memory
performance, mood, and neurobiology.

We will do this by comparing the unmedicated depressed patients with matched healthy controls
at baseline and then following the depressed patients over the course of eight weeks of
standardized antidepressant treatment to gauge which baseline abnormalities normalize over
the course of treatment.

Following an initial telephone screen to assess inclusion and exclusion criteria, the
evaluation will continue with an in-person evaluation to assess the presence or absence of
active medical history and history of major psychiatric illness, as well as review of the
consent document. If found to be eligible, participants would then be admitted to the study.

The next step for eligible, consenting depressed subjects and healthy controls is a baseline
hospital visit and baseline MRI. The baseline hospital visit will last about 4 hours. We will
begin the baseline visit by collecting a urine sample for a drug (and, for women, pregnancy)
test. As long as that is negative, we will then collect a blood sample of about 155cc. After
the blood draw, participants will complete cognitive tests and meet again with the study
psychiatrist. Participants will also complete a baseline Magnetic Resonance Imaging (MRI) and
Magnetic Resonance Spectroscopy (MRS) of their brain at the Veteran's Affairs (VA) Hospital
in San Francisco.

After the baseline hospital visit and MRI, depressed subjects (but not healthy controls) will
begin taking an FDA approved antidepressant, as prescribed by the study psychiatrist, for the
next 8 weeks while they are enrolled in the study. The specific drug will be decided upon
between the participant and the study psychiatrist at the in-person screening visit.

After 4 weeks, depressed participants will return to UCSF to meet again with the psychiatrist
to discuss symptoms and how to continue treatment; at that visit, they will have another
blood draw of 155cc (the same blood draw as at baseline). Healthy controls will return at
week 4 only for the blood draw.

4 weeks later (after 8 weeks in total), we will bring both depressed and healthy participants
back for an additional visit that will include the same blood draw, testing, and MRI as the
baseline visit. A physician-investigator will meet with the depressed subjects to review
their clinical responses to treatment and to make further treatment suggestions, which the
subjects may use in discussions of their future treatment options with their personal
physicians. If a decision is made to discontinue antidepressant treatment, the subjects will
be given instructions on how to withdraw from the medication, and will be given up to a 4
week supply of the drug to facilitate this withdrawal.

All participants must meet the following criteria:

- Age 21-60 and able to give informed consent.

- Not "needle phobic," by self-report.

- English-speaking (to allow accurate use of behavioral rating scales and verbal
cognitive tests).

- Females of child-bearing capacity must be non-pregnant (confirmed by urine pregnancy
test) and using effective non-hormonal birth control (e.g. abstinence, condoms, IUD).

- • Good general medical health; no significant uncontrolled illnesses that will
invalidate the designated outcome measures.

- Clinical labs (electrolytes, liver function test, CBC) with no clinically significant
abnormalities that result in medical treatment that will invalidate the designated
outcome measures.

- Negative urine toxicology (drugs of abuse) screen.

- Taking no medication or drugs likely to interfere with the study objectives (including
statins or medications that affect hormones [e.g. birth control pills or steroids]).

- Free of all psychotropic medications (including antidepressants) for at least 6 weeks
(with the exception of prn short-acting benzodiazepines or sedative-hypnotics, < 3
doses per week, and none for 5 drug half-lives before the study).

- No vaccines for at least 4 weeks prior to baseline blood draw (including the flu

- Not currently anemic (Hct of 36-48 for females and 38-54 for males, or Hgb of 12.5-20)
and has not donated blood for at least 8 weeks prior to baseline blood draw.

- No MRI exclusions (e.g. severe claustrophobia, metal implants, pacemakers, BMI >38).

- No neurological disorders and no history of concussion with a black-out that lasted >
10 minutes.

Additional criteria for Depressed Participants:

- Current DSM-5 diagnosis of Major Depressive Disorder, unipolar, with non-psychotic

- Baseline 17-item Hamilton Depression Rating Scale (HDRS) rating of >= 17, or Baseline
25-item HDRS rating of >= 20.

- Current depressive episode duration of > 6 weeks.

- No current, active suicidal intent; HDRS "suicidality" item rating <= 2 OR by
clinician determination.

- No recent (< 6 month) history of substance or alcohol use disorder(s), with the
exception of tobacco use (DSM-5 criteria).

- No current (in the last month) diagnosis of Post-Traumatic Stress Disorder (DSM-5

- No anticipated changes in psychotherapeutic interventions during the course of the

Additional criteria for Normal Controls:

• No history of DSM-5 Axis I diagnoses
We found this trial at
San Francisco, California 94143
Phone: 415-476-7433
San Francisco, CA
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